English to Polish Medical Medical: Instruments

Sterilizer time and temperature data collected on recording equipment found to be accurate and precise could establish that process parameters *** had been reliably delivered to **** previously processed loads. A retrospective qualification of the equipment could be performed to demonstrate that the recorded data represented conditions that were uniform throughout the chamber and that product load configurations, personnel practices, initial temperature, and other variables had been adequately controlled during the earlier runs.


http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInforma...